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Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Greater Occipital Nerve Block
Topiramate
Flunarizine
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Greater Occipital Nerve Block, Topiramate, Flunarizine

Eligibility Criteria

15 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Migraine diagnosis according to ICHD-2
  2. Ages between 15 -45 Volunteering
  3. Monthly attack number between 5-14
  4. BMI between 18-30
  5. w/o history of nephrolithiasis
  6. w/o history of DM, peripheral vascular disease
  7. w/o history of chronic systemic diseases (lung, heart,liver, kidney)
  8. w/o any detected CNS disease (including MS, movement disorders, CVD, primary or secondary tumors)
  9. w/o history of acute or chronic psychiatric disease
  10. w/o history of antiplatelet and anticoagulant medication
  11. w/o any combination of medication overuse headache or other primary headaches
  12. w/o previous medication of flunarizine and topiramate
  13. w/o previous application of GONB

Exclusion Criteria:

  1. Pregnancy
  2. Lost to follow up

    • exited with his/her own will
    • detected primary headache during follow up
    • cessation due to adverse effects of topiramate
    • cessation due to adverse effects of flunarizine

Sites / Locations

  • Ataturk University Resarch Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Greater Occipital Nerve Block

Topiramate

Flunarizine

Arm Description

The GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg), and 1 ml 0,9% NaCl. The solution is administered using a 22G × 1¼" (0.7 × 40mm) injector with the patient lying prone on the table. Injection is applied to medial of the occipital artery localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp is cleaned with iodine before the procedure, and the injections are performed bilaterally at a volume of 2 mL after negative aspiration for blood.

Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.

Flunarizine is introduced with a single dose of 10 mg/day.

Outcomes

Primary Outcome Measures

Visual Analog Scale
Range Pain 0-10, 0: No pain, 10: Worst Pain
Attack Frequencies
Number of headaches patients suffer in a month.

Secondary Outcome Measures

Full Information

First Posted
October 13, 2018
Last Updated
January 11, 2020
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT03712917
Brief Title
Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine
Official Title
Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine: A Randomised Parallel Group Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Preventive drug therapy in migraine aims to reduce the attack frequency, severity and duration of headache. Flunarizine and topiramate are widely used in the prevention of migraine attacks. Greater occipital nerve block (GONB) is an alternative treatment option for the prophylactic treatment of migraine. In this study, investigators compared the effectiveness of GONB, topiramate, and flunarizine in terms of reduction in post-treatment VAS scores and attack frequencies in patients with episodic migraine in a four-week period. Material and Methods: At least one hundred and twenty migraine patients are aimed to be randomly divided into three treatment groups, namely flunarizine (n=40, estimated), topiramate (n=40, estimated) and GONB (n=40, estimated). The patients will be followed up for four weeks and the attack frequencies and VAS scores will be recorded weekly. At the end of the fourth week, the response rates based on 50% and 75% or more reduction in the VAS scores and attack frequencies will be calculated. Group-wise comparisons will be assessed statistically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Greater Occipital Nerve Block, Topiramate, Flunarizine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Greater Occipital Nerve Block
Arm Type
Active Comparator
Arm Description
The GONB solution is prepared with 1 ml triamcinolone (40mg), 2 ml bupivacaine (10 mg), and 1 ml 0,9% NaCl. The solution is administered using a 22G × 1¼" (0.7 × 40mm) injector with the patient lying prone on the table. Injection is applied to medial of the occipital artery localized at the medial one-third of the superior nuchal line between the occipital tubercle and mastoid process. The scalp is cleaned with iodine before the procedure, and the injections are performed bilaterally at a volume of 2 mL after negative aspiration for blood.
Arm Title
Topiramate
Arm Type
Active Comparator
Arm Description
Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.
Arm Title
Flunarizine
Arm Type
Active Comparator
Arm Description
Flunarizine is introduced with a single dose of 10 mg/day.
Intervention Type
Procedure
Intervention Name(s)
Greater Occipital Nerve Block
Intervention Description
An enjection to paralyze the occipital nerve.
Intervention Type
Drug
Intervention Name(s)
Topiramate
Intervention Description
An antiepileptic agent used for migraine prophylaxis.
Intervention Type
Drug
Intervention Name(s)
Flunarizine
Intervention Description
A calcium overload blocker agent used for migraine prophylaxis.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
Range Pain 0-10, 0: No pain, 10: Worst Pain
Time Frame
Post treatment 4 weeks
Title
Attack Frequencies
Description
Number of headaches patients suffer in a month.
Time Frame
Post treatment 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Migraine diagnosis according to ICHD-2 Ages between 15 -45 Volunteering Monthly attack number between 5-14 BMI between 18-30 w/o history of nephrolithiasis w/o history of DM, peripheral vascular disease w/o history of chronic systemic diseases (lung, heart,liver, kidney) w/o any detected CNS disease (including MS, movement disorders, CVD, primary or secondary tumors) w/o history of acute or chronic psychiatric disease w/o history of antiplatelet and anticoagulant medication w/o any combination of medication overuse headache or other primary headaches w/o previous medication of flunarizine and topiramate w/o previous application of GONB Exclusion Criteria: Pregnancy Lost to follow up exited with his/her own will detected primary headache during follow up cessation due to adverse effects of topiramate cessation due to adverse effects of flunarizine
Facility Information:
Facility Name
Ataturk University Resarch Hospital
City
Erzurum
ZIP/Postal Code
25000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Diener H-C, Goadsby PJ. Migraine In: Brandt T, Caplan L, Dichgans J, Diener H-C, Kennard C (eds) Course and treatment of neurological disorders. 2nd edition. Academic Press, San Diego, (2003). pp 1-16.
Results Reference
background
Citation
Baker C. Double-blind evaluation of flunarizine and placebo in the prophylactic treatment of migraine. Headache 1987; 27:288.
Results Reference
background
PubMed Identifier
15096395
Citation
Silberstein SD, Neto W, Schmitt J, Jacobs D; MIGR-001 Study Group. Topiramate in migraine prevention: results of a large controlled trial. Arch Neurol. 2004 Apr;61(4):490-5. doi: 10.1001/archneur.61.4.490.
Results Reference
background
PubMed Identifier
1454403
Citation
Bovim G, Sand T. Cervicogenic headache, migraine without aura and tension-type headache. Diagnostic blockade of greater occipital and supra-orbital nerves. Pain. 1992 Oct;51(1):43-48. doi: 10.1016/0304-3959(92)90007-X.
Results Reference
background

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Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine

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